- Public Citizen and the American Medical Student Association (AMSA) sent a third follow-up letter to HHS' Office for Human Research Protections (OHRP) urging it to investigate the clinical trial iCompare because it "violates basic ethical principles and federal regulatory requirements related to the protection of human subjects."
- In Wednesday's letter, the groups highlighted several different findings from NIH documents they recently obtained through a Freedom of Information Act request that supports their concern with the trial. The first letter was sent in November 2015 and the second in February.
- OHRP has yet to initiate an investigation, even though it received the same documents that the groups obtained about two months ago, according to a press release.
Trials in which humans are research subjects are required to be reviewed by an institutional review board (IRB). iCOMPARE involves internal medicine residents at 63 residency training programs in the U.S. and many of those who are first-year residents work shifts of at least 28 consecutive hours.
After analyzing the NIH documents, Public Citizen and AMSA found at least 56 internal medicine training programs in the iCompare trial either did not go through an IRB review or went through an expedited process the trial was not qualified for. Also, trial researchers indicated it's possible that residents are being exposed to "increased risks of motor vehicle accidents, needle-stick injuries that can expose the residents to bloodborne pathogens, and depression due to sleep deprivation."
“It is urgent that the iCOMPARE trial be suspended and investigated given that residents and their patients continue to be put at risk,” Director of Public Citizen’s Health Research Group Michael Carome said in a prepared statement.
"The newly obtained documents show overwhelming evidence of egregious ethical and regulatory lapses regarding the design, conduct and oversight of the trial," Carome added. "iCOMPARE epitomizes a human subjects protection system that has failed dismally at all levels.”